Percutaneous valve, system and method

ABSTRACT

Apparatus, systems, and methods for percutaneous valve replacement and/or augmentation are provided. The apparatus includes a valve having a valve frame, a valve leaflet coupled to the valve frame, and a leaflet transition member coupled to the valve leaflet. The valve leaflet and leaflet transition member can transition from a first position where the valve leaflet and leaflet frame are at least partially outside a lumen of the valve frame to a second position where the valve leaflet and the leaflet transition member are within the lumen of the valve frame.

This application claims priority from U.S. Provisional Application Ser.No. 60/899,446, filed Feb. 5, 2007, the entire content of which isincorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates generally to apparatus', systems, andmethods for use in the vascular system; and more particularly to apercutaneous valve, system, and method for use in the vasculaturesystem.

BACKGROUND

Valves can become damaged and/or diseased for a variety of reasons.Damaged and/or diseased valves are grouped according to which valve orvalves are involved, and the amount of blood flow that is disrupted bythe damaged and/or diseased valve. For example, the most common cardiacvalve diseases occur in the mitral and aortic valves. Diseases of thetricuspid and pulmonary valves are fairly rare.

The aortic valve regulates the blood flow from the heart's leftventricle into the aorta. The aorta is the main artery that suppliesoxygenated blood to the body. As a result, diseases of the aortic valvecan have a significant impact on an individual's health. Examples ofsuch diseases include aortic regurgitation and aortic stenosis.

Aortic regurgitation is also called aortic insufficiency or aorticincompetence. It is a condition in which blood flows backward from awidened or weakened aortic valve into the left ventricle of the heart.In its most serious form, aortic regurgitation is caused by an infectionthat leaves holes in the valve leaflets. Symptoms of aorticregurgitation may not appear for years. When symptoms do appear, it isbecause the left ventricle must work harder relative to an uncompromisedaortic valve to make up for the backflow of blood. The ventricleeventually gets larger and fluid backs up.

Aortic stenosis is a narrowing or blockage of the aortic valve. Aorticstenosis occurs when the valve leaflets of the aorta become coated withdeposits. The deposits change the shape of the leaflets and reduce bloodflow through the valve. Again, the left ventricle has to work harderrelative to an uncompromised aortic valve to make up for the reducedblood flow. Over time, the extra work can weaken the heart muscle.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1B provide an embodiment of a valve of the present disclosure.

FIGS. 2A-2B provide an embodiment of a valve of the present disclosure.

FIGS. 3A-3C illustrate an embodiment of a system according to thepresent disclosure.

DETAILED DESCRIPTION

Embodiments of the present disclosure are directed to an apparatus,system, and method for percutaneous valve replacement and/oraugmentation. For example, the apparatus can include a valve that can beused to replace an incompetent valve (e.g., an aortic valve, a mitralvalve, a tricuspid valve, or a pulmonary valve) or vein in a body lumen.Embodiments of the valve include a valve frame having frame members thatdefine a lumen, and a valve leaflet coupled to the valve frame.

In the various embodiments, the valve leaflets extend away from thelumen of the valve. This configuration allows for more flexibility inthe valve frame design as well as the valve leaflet design since thevalve is not delivered to a treatment site with the valve leafletsinside the valve frame. In addition to more flexibility in design, thisconfiguration allows for a lower profile of the delivered valve sincethe valve leaflets are outside the valve frame, allowing the valve frameto be compressed to a greater degree. For example, the valve frame canbe at least partially balloon deployed without compressing, orsandwiching, the valve leaflets between the inflatable balloon and thevalve frame. Once the valve frame is deployed, the valve leaflets andvalve frame can be transitioned to within the lumen of the valve frameand the leaflet transition member can be expanded to secure the leaflettransition member and the valve leaflets into a position to function asa valve. Embodiments of the present disclosure can be used as aprosthetic cardiac valve and/or a prosthetic venous valve, as well asother valves.

The figures herein follow a numbering convention in which the firstdigit or digits correspond to the drawing figure number and theremaining digits identify an element or component in the drawing.Similar elements or components between different figures may beidentified by the use of similar digits. For example, 110 may referenceelement “10” in FIG. 1, and a similar element may be referenced as 210in FIG. 2. As will be appreciated, elements shown in the variousembodiments herein can be added, exchanged, and/or eliminated so as toprovide any number of additional embodiments of valve and/or system. Inaddition, as will be appreciated the proportion and the relative scaleof the elements provided in the figures are intended to illustrate theembodiments of the present invention, and should not be taken in alimiting sense.

Various embodiments of the present disclosure are illustrated in thefigures. Generally, the valve can be implanted within the fluidpassageway of a body lumen, for example, for replacement or augmentationof a valve structure within the body lumen (e.g., an aortic valve), toregulate the flow of a bodily fluid through the body lumen in a singledirection.

FIGS. 1A and 1B provide an embodiment of a valve 100 of the presentdisclosure. FIG. 1A illustrates the valve 100 with the valve leaflet 104in a first position, while FIG. 1B illustrates the valve 100 with thevalve leaflet 104 in a second position. The valve 100 includes a valveframe 102 and a valve leaflet 104 coupled to the valve frame 102. Thevalve frame 102 also includes frame members 106 that define a lumen 108.The valve 100 also includes a leaflet transition member 110 coupled toat least a portion of the valve leaflet 104.

As discussed herein, FIG. 1A illustrates the valve leaflet 104 andleaflet transition member 110 in a first position, where the valveleaflet 104 and leaflet transition member 110 are at least partiallyoutside the lumen 108 of the valve frame 102 and extend away from thelumen 108. The valve leaflet 104 can also include a leaflet frame 111that is coupled to a portion of the peripheral edge 122 of the valveleaflet 104. In some embodiments, the leaflet frame 111 can have aU-shape, leaving a portion of a distal end 118 of the valve leaflet 104free to move between an open and closed position to function as a valve.

In some embodiments, the leaflet frame 111 can be coupled to the leaflettransition member 110. For example, the leaflet frame 111 can be hingedto the leaflet transition member 110 to allow the leaflet transitionmember 110 to move inside the leaflet frame 111 and invert the leafletframe 111 from the first position, as shown in FIG. 1A, to the secondposition, as shown in FIG. 1B. The valve leaflet 104 can be coupled tothe leaflet frame 111 in a variety of ways including sewing, suturing,and/or arc welding, among other methods.

In some embodiments, the valve frame 102 can have an elongate tubularstructure with a proximal end 112 and a distal end 114. In someembodiments, portions of the frame members 106 can define the proximaland distal ends 112, 114 of the valve frame 102. In addition, the valveleaflet 104 can have a proximal end 116 and a distal end 118, where aportion of the distal end 118 of the valve leaflet 104 can be coupledadjacent to the proximal end 112 of the valve frame 102 at junctionpoints 120. As used herein, “junction points” refer to places on thevalve frame 102 where the valve leaflet 104 is coupled to the valveframe 102. In some embodiments, the junction points 120 can be locatedat a number of different positions on the valve frame 102. In someembodiments, the junction points 120 can be located at the same relativeposition around the valve frame 102. For example, when a valve 100includes two valve leaflets 104, the junction points 120 can be setopposite each other in a mirror image relationship.

In embodiments where there are more than two leaflets 104, the junctionpoints 120 can be set along the valve frame 102 at positions that areequidistant from each other. This aspect of the disclosure isillustrated in FIG. 1, which shows the valve 100 with three valveleaflets 104 having three junction points 120 set on the valve frame 102at positions that are equidistant from each other. Alternatively, thejunction points 120 can be at different relative locations along thevalve frame 102. For the various embodiments, the junction points 120can be located on the valve frame 102 such that the valve leaflet 104can transition from a first position as shown in FIG. 1A to a secondposition shown in FIG. 1B, as will be discussed herein.

As illustrated in FIG. 1A, the valve 100 can include the leaflettransition member 110 coupled to at least a portion of the valve leaflet104 and/or the leaflet frame 111. In some embodiments, the leaflettransition member 110 can be a ring structure that is coupled to theproximal end 116 of the valve leaflet 104. The leaflet transition member110 can be expandable from a first diameter to a second diameter. Asshown in FIG. 1A, the leaflet transition member 110 in the firstposition can have the first diameter. In various embodiments, theleaflet transition member 110 can have a serpentine shape in order toallow the leaflet transition member 110 to expand from the firstdiameter to the second diameter. The leaflet transition member 110 canalso have other shapes, for example, the leaflet transition member 110can include leaflet transition member 110 portions that can form a coil.The coil portions can allow the leaflet transition member 110 to have afirst diameter in the first position and expand to a second diameter.The leaflet transition member 110 can also have other shapes.

In some embodiments, the leaflet transition member 110 can be formed ofa shape-memory material. Examples of shape-memory materials includeshape memory plastics, polymers, thermoplastic materials, andmetal-alloys which are inert in the body. Some shape-memory materials,(e.g., nickel-titanium alloys) can be temperature-sensitive and changeshape at a designated temperature or temperature range. Shape memorymetal-alloys are generally made from nickel and titanium in specificratios, commonly known as Nitinol. Other materials are also possible.

FIG. 1B provides an embodiment of a valve 100 of the present disclosurewhen the valve leaflets 104 and leaflet frame 110 are in the secondposition. As illustrated, the valve leaflet 104 and leaflet transitionmember 110 can transition from the first position to the second positionby pivoting the valve leaflet 104 inside the valve frame 102 at thejunction points 120. In the second position, the proximal end 116 of thevalve leaflet 104 and at least a portion of the leaflet transitionmember 110 are within the lumen 108 of the valve frame 102. In someembodiments, the leaflet transition member 110 in the second positioncan be coupled adjacent to the distal end 114 of the valve frame 102,for example, the leaflet transition member 110 can be coupled to framemembers 106 on the distal end 114 of the valve frame 102.

As discussed herein, the leaflet transition member 110 can expand from afirst diameter to a second diameter. The leaflet transition member 110can expand to the second diameter to secure the leaflet frame 110 to thevalve frame 102 and/or to secure the leaflet transition member 110 inthe second position. As illustrated in FIG. 1B, the leaflet transitionmember 110 can have a serpentine shape to allow the leaflet transitionmember 110 to expand, however, the serpentine shape can also allowportions of the leaflet transition member 110 to expand through thevalve frame 102 and between the frame members 106. By expanding throughthe valve frame 102 and between the frame members, the leaflettransition member 110 can be held in the second position.

For the various embodiments, the valve frame 102 can be formed of aballoon expandable material, as discussed herein. The valve frame 102can also be formed of a material with a spring bias. The valve frame 102can also be a shape memory material, as discussed herein. Othermaterials are also possible.

For the various embodiments, the frame members 106 and/or the leaflettransition member 110 can have similar and/or different cross-sectionalgeometries along their length. The similarity and/or the differences inthe cross-sectional geometries can be selected based on one or moredesired functions to be elicited from each portion of the valve frame102. Examples of cross-sectional geometries include rectangular,non-planar configuration (e.g., bent), round (e.g., circular, oval,and/or elliptical), polygonal, arced, and tubular. Other cross-sectionalgeometries are possible.

The valve 100 can further include one or more radiopaque markers (e.g.,tabs, sleeves, welds). For example, one or more portions of the valveframe 102 can be formed from a radiopaque material. Radiopaque markerscan be attached to and/or coated onto one or more locations along thevalve frame 102. Examples of radiopaque material include, but are notlimited to, gold, tantalum, and platinum. The position of the one ormore radiopaque markers can be selected so as to provide information onthe position, location, and orientation of the valve 100 during itsimplantation.

The valve 100 further includes the leaflets 104 having surfaces defininga reversibly sealable opening for unidirectional flow of a liquidthrough the valve 100. Each of the valve leaflets 104 are coupled to thevalve frame 102, where the leaflets 104 can repeatedly move between anopen state and a closed state for unidirectional flow of a liquidthrough a lumen of the valve 100. For example, the leaflets 104 can becoupled to the proximal end 112 of the valve frame 102 so as to span andcontrol fluid flow through the lumen of the valve 100. For the presentembodiment, the valve 100 includes three of the valve leaflets 104 for atri-leaflet configuration. As appreciated, mono-leaflet, bi-leafletand/or other multi-leaflet configurations are also possible.

In some embodiments, the leaflets 104 can be derived from autologous,allogeneic or xenograft material. As will be appreciated, sources forxenograft material (e.g., cardiac valves) include, but are not limitedto, mammalian sources such as porcine, equine, and sheep. Additionalbiologic materials from which to form the valve leaflets 104 include,but are not limited to, explanted veins, pericardium, facia lata,harvested cardiac valves, bladder, vein wall, various collagen types,elastin, intestinal submucosa, and decellularized basement membranematerials, such as small intestine submucosa (SIS), amniotic tissue, orumbilical vein.

Alternatively, the leaflets 104 can be formed from a synthetic material.Possible synthetic materials include, but are not limited to, expandedpolytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE),polystyrene-polyisobutylene-polystyrene (SIBS), polyurethane, segmentedpoly(carbonate-urethane), polyester, polyethylene (PE), polyethyleneterephthalate (PET), silk, urethane, Rayon, Silicone, or the like. In anadditional embodiment, the synthetic material can also include metals,such as stainless steel (e.g., 316L) and nitinol. These syntheticmaterials can be in a woven, a knit, a cast or other known physicalfluid-impermeable or permeable configurations. In addition, gold platedmetals can be embedded in the leaflet 104 material (e.g., a sandwichconfiguration) to allow for visualization of the leaflets 104 postplacement.

As will be appreciated, the valve 100 can be treated and/or coated withany number of surface or material treatments. Examples of suchtreatments include, but are not limited to, bioactive agents, includingthose that modulate thrombosis, those that encourage cellular ingrowth,throughgrowth, and endothelialization, those that resist infection, andthose that reduce calcification.

FIGS. 2A and 2B provide an embodiment of a valve 200 of the presentdisclosure. As discussed herein, the valve 200 includes a valve frame202 and a valve leaflet 204 coupled to the valve frame 202. The valveframe 202 also includes frame members 206 that define a lumen 208. Asshown in FIGS. 2A and 2B, the valve leaflets 204 can include a leafletframe 211, as discussed herein, coupled to at least a portion of theperipheral edge 222 of the valve leaflets 204. In such embodiments, theleaflet frame 211 can act as the leaflet transition member 210.

FIG. 2A illustrates the valve leaflet 204 and leaflet transition member210 (i.e., leaflet frame 211) in a first position, where the valveleaflet 204 and leaflet transition member 210 are at least partiallyoutside the lumen 208 of the valve frame 202 and extend away from thelumen 208. FIG. 2B illustrates the valve 200 where the valve leaflet 204and leaflet transition member 210 are in a second position within thelumen 208 of the valve frame 202, as discussed herein.

As shown in FIGS. 2A and 2B, in some embodiments, the leaflet frame 211can be coupled to a portion of a peripheral edge 222 of the valveleaflet 204. In such embodiments, the leaflet frame 211 can form theoutside boundary of a portion of the valve leaflet 204 and can hold thevalve leaflet 204 in a desired position. As discussed herein, the valveleaflet 204 can have a proximal end 216 and a distal end 218, where aportion of the distal end 218 of the valve leaflet 204 can be coupledadjacent to the proximal end 212 of the valve frame 202 at junctionpoints 220. In some embodiments, the valve leaflet 204 can be coupled tothe valve frame 202 such that the valve leaflet 204 can pivot inside thevalve frame 302 at the junction points 220.

In other embodiments, the leaflet transition member 210 (i.e., leafletframe 211) can be coupled to the peripheral edge 222 of the valveleaflet 204 such that the leaflet transition member 210 is coupled tothe proximal end 212 of the valve frame 202. In such embodiments, theleaflet transition member 210 can be hinged to a portion of the valveframe 202 to couple the valve frame 202 and the valve leaflet 204. Also,hinging the leaflet transition member 210 to the valve frame 202 canallow the leaflet transition member 210 and the valve leaflet 204 totransition from the first position to the second position, as shown inFIGS. 2A and 2B.

In addition, as discussed herein, the leaflet transition member 210 canbe coupled to the valve frame 202 to hold the leaflet frame 210 in thesecond position. In such embodiments, the leaflet transition member 210can include mechanical members 205 to hold the leaflet transition member210 to the frame members 206 of the valve frame 202. One embodiment of amechanical member 205 is shown in FIG. 2A as a close-up view. In thisembodiment, the mechanical member 205 can be in the form of a clip,where a frame member 206 can slide into the clip 205 to secure theleaflet frame 210 to the valve frame 202. In another embodiment, themechanical member 205 can be a hook that hooks the leaflet transitionmember 210 to the frame members in several different locations. Othermechanical member 205 configurations are also possible.

FIGS. 3A-3C illustrate an embodiment of a system 324 according to thepresent disclosure. The system 324 includes a valve 300, as describedherein, releasably joined to an elongate delivery catheter 326 and anexpandable balloon 328 positioned around at least a portion of theelongate delivery catheter 326. The system 324 also includes aretractable sheath 330 positioned around at least a portion of theelongate delivery catheter 326. Also, a portion of the valve 300 ispositioned between the elongate delivery catheter 326 and theretractable sheath 330. For example, FIG. 3A illustrates an embodimentin which the retractable sheath 330 is positioned around at least aportion of the delivery catheter 326 to releasably hold the leaflettransition member 310 in a delivery state.

In some embodiments, the retractable sheath 330 can be positioned suchthat the retractable sheath holds the valve frame 302 and the leaflettransition member 310 in a delivery state. In such embodiments, theretractable sheath 330 can be partially retracted to allow the valveframe 302 to be radially expanded while holding the leaflet transitionmember 310 in the delivery state. FIG. 3B illustrates an embodiment inwhich valve 300 has expanded to its deployed state, as discussed herein.

In the embodiments illustrated in FIGS. 3A-3C, the delivery catheter 326includes an elongate body having a proximal end 332 and a distal end334. A catheter lumen 336 can extend through the proximal and distalends 332, 334. In some embodiments, the catheter lumen 336 can receive aguidewire for guiding the placement of the valve 300 in the vasculature.

In some embodiments, the elongate delivery catheter 326 can include adistal tip 338. The distal tip 338 can have a conical configuration,where the tip 338 diameter decreases in size to a point at the distalend 334 of the elongate delivery catheter 338. The distal tip 338 canalso include a recessed lip 340 in which a distal portion of theretractable sheath 330 can releasably seat. In embodiments including aretractable sheath 330 extending over the valve frame 302, seating thedistal portion of the retractable sheath 330 in the recessed lip 340 canhelp to hold the valve 300 in its delivery state.

In addition, in such embodiments, the retractable sheath 330 can movelongitudinally (e.g., slide) relative the delivery catheter 326 to allowthe valve 300 to radially expand from its delivery state to its deployedstate. In some embodiments, moving the retractable sheath 330 relativethe delivery catheter 326 can be accomplished by pulling a proximal end342 of the sheath 330 relative a proximal end 332 of the deliverycatheter 326.

FIG. 3B illustrates an embodiment where the valve 300 has been radiallyexpanded. In some embodiments, the valve 300 can be balloon expandable.In other embodiments, the retractable sheath 330, if positioned over thevalve frame 302, can be retracted relative the valve 300 to allow thevalve 300 to be radially expanded using the expandable balloon 328. Insuch embodiments, the elongate delivery catheter 326 can include a lumenfluidly attached to the expandable balloon 328 to allow the balloon 328to be filled with fluid to radially expand the balloon 328, and thus thevalve 300.

In some embodiments, the valve 300 can be formed of a material with aspring bias, where the valve 300 can expand when the sheath 330 has beenremoved. In such embodiments, the expandable balloon 328 can be used toposition the valve 300 and/or secure the valve 300 inside a body lumen.Examples of materials with a spring bias can include, but are notlimited to, medical grade stainless steel (e.g., 316L), titanium,tantalum, platinum alloys, niobium alloys, cobalt alloys, alginate, orcombinations thereof.

In some embodiments, the expandable balloon 328 can be a perfusionballoon. A perfusion balloon can be used to radially expand the valveframe 302 while allowing fluid, for example, blood, to pass through thedelivery catheter 326 and valve 300 while the valve 300 is beingpositioned in the vasculature.

In the embodiment illustrated in FIGS. 3A-3C, the valve 300 includes avalve frame 302 having frame members defining a lumen 308, a valveleaflet 304 attached to a portion of the valve frame 302, and a leaflettransition member 310 attached to at least a portion of the valveleaflet 304. FIG. 3A illustrates an embodiment where the valve leaflet304 and leaflet transition member 310 are in a first position extendingaway from the lumen 308 of the valve 300. Although the embodimentsillustrated in FIGS. 3A-3C show a valve 300 including a leaflettransition member 310 and a leaflet frame 311, the present disclosureincludes embodiments where the leaflet frame 310 acts as the leaflettransition member 310, as discussed herein.

To transition the valve leaflets 304 and leaflet transition member 310from the first position to a second position within the lumen 308 of thevalve frame 302, the elongate delivery catheter 326 can include a numberof elongate push members 344 releasably coupled to the leaflettransition member 310. The elongate push members 344 can be positionedaround the elongate delivery catheter 326, and can be used to push theleaflet transition member 310 inside the lumen 308 of the valve 300.

In some embodiments, the elongate push members 344 can move in alongitudinal direction relative the elongate delivery catheter 326. Theelongate push members 344 can be formed of a plastic material, where theelongate push members 344 are moved into the lumen 308 of the valve 300to push the leaflet transition member 310 and the valve leaflet 304 fromthe first position to the second position. The elongate push members 344can also be formed of different materials. For example, the elongatepush members 344 can be formed of a wire or thread releasably attachedto the leaflet transition member 310. As such, as the elongate pushmembers 344 are moved into the lumen 308 of the valve 300, the elongatepush members 344 would pull the leaflet transition member 310 and thevalve leaflet 304 from the first position to the second position. Othermethods of transitioning the leaflet transition member 310 and the valveleaflet 304 from the first position to the second position are alsopossible.

As discussed herein, FIG. 3B illustrates an embodiment where the valveframe 302 is radially expanded. Also shown is how the leaflet transitionmember 310 can remain in a contracted state while the valve frame 302 isexpanded. In some embodiments, the leaflet transition member 310 can beformed of a shape-memory material, such as a nickel-titanium alloy,where the leaflet transition member 310 and/or leaflet frame 311 isrestrained in a contracted state by the retractable sheath 330.

In some embodiments, the leaflet transition member 310 is formed of ashape memory material, as discussed herein. In such embodiments, theretractable sheath 330 can be used to hold the leaflet transition member310 in the first position while the valve frame 302 is radiallyexpanded.

FIG. 3B also illustrates how a portion of the leaflet frame 311 canexpand when the valve frame 302 is radially expanded. In someembodiments, the leaflet frame 311 can be coupled to the proximal end312 of the valve frame 302 such that when the valve frame 302 isradially expanded, the leaflet frame 311 is coupled to the valve frame302 at junction points 320 that are equidistant apart, as discussedherein.

In addition, in some embodiments, the leaflet frame 311 can be formed ofa shape memory material to allow the leaflet frame 311 to deform whenthe valve frame 302 is expanded and the leaflet transition member 310 isheld in the delivery state. In such embodiments, once the valve frame302 is expanded and the valve leaflet 304 and leaflet transition member310 are in the second position, the leaflet frame 311 can transition toa deployed state to hold the valve leaflet 304 in a position to act as avalve.

As discussed herein, the number of elongate push members 344 can be usedto push the leaflet transition member 310 inside the lumen 308 of thevalve frame 302 to place the valve leaflet 304 and leaflet transitionmember 310 into the second position. Once the leaflet transition member310 is inside the lumen 308, the leaflet transition member 310 can beradially expanded inside the valve frame 302 and the number of elongatemembers 344 can be released from the leaflet transition member 310. Insome embodiments, the leaflet transition member 310 can be formed of amaterial with a spring bias, as discussed herein, and expand when theretractable sheath 330 is retracted relative the valve 300 to releasethe leaflet transition member 310 while the elongate push members 344hold the leaflet transition member 310 in place within the lumen 308 ofthe valve 300. Once the leaflet transition member 310 is expanded, theelongate push members 344 and the delivery catheter 326 can be retractedthrough the valve 300.

Alternatively, in embodiments where the leaflet transition member 310 isformed of a shape memory material, the leaflet frame 310 can radiallyexpand when the retractable sheath 330 is retracted relative the valve300 and the leaflet transition member 310 warms to a certaintemperature, for example, at or below normal body temperature (e.g., 37degrees Celsius).

FIG. 3C illustrates an embodiment of the valve frame 302 radiallyexpanded, where the valve leaflet 304 and leaflet transition member 310are in the second position. As illustrated, once the leaflet transitionmember 310 and the valve frame 302 are expanded, the expandable balloon328 and distal tip 338 can be retracted through the lumen 308 of thevalve frame 302.

In some embodiments, the leaflet transition member 310 can be secured tothe valve frame 302 once the leaflet transition member 310 is in thesecond position and both the leaflet transition member 310 and the valveframe 302 are radially expanded. For example, as discussed herein, theleaflet transition member 310 can expand from a first diameter to asecond diameter where portions of the leaflet transition member 310extend through the valve frame 302 and between the frame members 306 tosecure the leaflet transition member 310 in the second position. Inother embodiments, the leaflet transition member 310 and/or leafletframe 311 can include mechanical members, as discussed herein, to securethe leaflet transition member 310 and/or leaflet frame 311 to the valveframe 302. A combination of mechanical members and expanding the leaflettransition member 310 to extend portions of the leaflet transitionmember 310 through the valve frame 302 and between the frame members 306is also possible.

Embodiments of the system 324 can further include an expandable filterthat forms a portion of the retractable sheath. Examples of such anembodiment can be found in U.S. Provisional Patent application60/899,444 and co-pending U.S. patent application Ser. No. 12/012,911entitled “Percutaneous Valve, System and Method”, both of which arehereby incorporated by reference in their entirety.

Each of the delivery catheter 326, the retractable sheath 330, and/orthe second retractable sheath 346 can be formed of a number ofmaterials. Materials include polymers, such as PVC, PE, POC, PET,polyamide, mixtures, and block co-polymers thereof. In addition, each ofthe delivery catheter 326, the retractable sheath 330, and/or the secondretractable sheath 346 can have a wall thickness and an inner diametersufficient to allow the structures to slide longitudinally relative eachother, as described herein, and to maintain the valve 300 in a deliverystate, as discussed herein.

In an additional embodiment, the valve 300 can further include a sealingmaterial 348 positioned on the periphery of the valve frame 302. In oneembodiment, once implanted the sealing material 348 can swell due thepresence of liquid to occupy volume between the valve frame 302 and thetissue on which the valve 300 has been implanted so as to preventleakage of the liquid around the outside of the valve 300.

Embodiments can also include a sealing material positioned on a portionof the peripheral edge 322 of the leaflet frame 311 to seal the leafletframe 311 to the valve frame 302.

A variety of suitable materials for the sealing material 348 arepossible. For example, the sealing material 348 can be selected from thegeneral class of materials that include polysaccharides, proteins, andbiocompatible gels. Specific examples of these polymeric materials caninclude, but are not limited to, those derived from poly(ethylene oxide)(PEO), poly(ethylene glycol) (PEG), poly(vinyl alcohol) (PVA),poly(vinylpyrrolidone) (PVP), poly(ethyloxazoline) (PEOX)polyaminoacids, pseudopolyamino acids, and polyethyloxazoline, as wellas copolymers of these with each other or other water soluble polymersor water insoluble polymers. Examples of the polysaccharide includethose derived from alginate, hyaluronic acid, chondroitin sulfate,dextran, dextran sulfate, heparin, heparin sulfate, heparan sulfate,chitosan, gellan gum, xanthan gum, guar gum, water soluble cellulosederivatives, and carrageenan. Examples of proteins include those derivedfrom gelatin, collagen, elastin, zein, and albumin, whether producedfrom natural or recombinant sources.

In an additional embodiment, the valve 300 of the present disclosure caninclude anchoring members attached to the valve frame 302 or framemembers 306. Anchoring members can include barbs, hooks, etc.

The embodiments of the valve described herein may be used to replace,supplement, or augment valve structures within one or more lumens of thebody. For example, embodiments of the present invention may be used toreplace an incompetent cardiac valve of the heart, such as the aortic,pulmonary and/or mitral valves of the heart. In one embodiment, thenative cardiac valve can either remain in place or be removed (e.g., viaa valvoplasty procedure) prior to implanting the cardiac valve of thepresent disclosure.

In addition, positioning the system having the valve as discussed hereinincludes introducing the system into the cardiovascular system of thepatient using minimally invasive percutaneous, transluminal techniques.For example, a guidewire can be positioned within the cardiovascularsystem of a patient that includes the predetermined location. The systemof the present disclosure, including the valve as described herein, canbe positioned over the guidewire and the system advanced so as toposition the valve at or adjacent the predetermined location. In oneembodiment, radiopaque markers on the catheter and/or the valve, asdescribed herein, can be used to help locate and position the valve.

The valve can be deployed from the system at the predetermined locationin any number of ways, as described herein. In one embodiment, valve ofthe present disclosure can be deployed and placed in any number ofcardiovascular locations. For example, valve can be deployed and placedwithin a major artery of a patient. In one embodiment, major arteriesinclude, but are not limited to, the aorta. In addition, valves of thepresent invention can be deployed and placed within other major arteriesof the heart and/or within the heart itself, such as in the pulmonaryartery for replacement and/or augmentation of the pulmonary valve andbetween the left atrium and the left ventricle for replacement and/oraugmentation of the mitral valve. Other locations are also possible.

Once implanted, the valve can provide sufficient contact with the bodylumen wall to prevent retrograde flow between the valve and the bodylumen wall, and to securely located the valve and prevent migration ofthe valve. The valve described herein also displays sufficientflexibility and resilience so as to accommodate changes in the bodylumen diameter, while maintaining the proper placement of valve. Asdescribed herein, the valve can engage the lumen so as to reduce thevolume of retrograde flow through and around valve. It is, however,understood that some leaking or fluid flow may occur between the valveand the body lumen and/or through valve leaflets.

Embodiments of the present disclosure also include a valve that includesa valve frame having a lumen; a valve leaflet attached to a portion ofthe valve frame; a leaflet transition member attached to at least aportion of the valve leaflet, where the valve leaflet and leaflettransition member extend away from the lumen in a first position andtransition into a second position in which the valve leaflet and leaflettransition member are inside the lumen of the valve frame. For theembodiments of the valve, the leaflet transition member in the secondposition is coupled to the frame members. For the embodiments of thevalve, the leaflet transition member expands from a contracted state inthe first position to an expanded state in the second position. For theembodiments of the valve, the leaflet transition member has a serpentineshape in the contracted state in order to expand from a first diameterto a second diameter in the expanded state. For the embodiments of thevalve thee valve frame includes frame members defining the lumen and theleaflet transition member in the expanded state includes at least aportion of the leaflet transition member that is expanded between theframe members to secure the leaflet transition member in the secondposition.

Embodiments of the present disclosure also include a structure forforming a valve that include a valve frame having a distal end and aproximal end, and frame members defining a lumen; a valve leaflet havinga distal end and a proximal end, where a portion of the distal end ofthe valve leaflet is coupled adjacent to the proximal end of the valveframe; and a leaflet transition member coupled to at least a portion ofthe valve leaflet, where the valve leaflet and the leaflet transitionmember in a first position are at least partially outside the lumen ofthe valve frame with the proximal end of the valve leaflet extendingaway from both the distal end and the proximal end of the valve frame.

For the embodiments of the structure, the valve leaflet and leaflettransition member transition from the first position to a secondposition in which the proximal end of the leaflet and at least a portionof the leaflet transition member are within the lumen of the valveframe. For the embodiments of the structure, the leaflet transitionmember is a ring structure coupled to the proximal end of the valveleaflet. For the embodiments of the structure, the valve leafletincludes a leaflet frame coupled to a portion of a peripheral edge ofthe valve leaflet, and the leaflet transition member is coupled to theleaflet frame.

While the present invention has been shown and described in detailabove, it will be clear to the person skilled in the art that changesand modifications may be made without departing from the spirit andscope of the invention. As such, that which is set forth in theforegoing description and accompanying drawings is offered by way ofillustration only and not as a limitation. The actual scope of theinvention is intended to be defined by the following claims, along withthe full range of equivalents to which such claims are entitled. Inaddition, one of ordinary skill in the art will appreciate upon readingand understanding this disclosure that other variations for theinvention described herein can be included within the scope of thepresent invention.

In the foregoing Detailed Description, various features are groupedtogether in several embodiments for the purpose of streamlining thedisclosure. This method of disclosure is not to be interpreted asreflecting an intention that the embodiments of the invention requiremore features than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter lies in less than allfeatures of a single disclosed embodiment. Thus, the following claimsare hereby incorporated into the Detailed Description, with each claimstanding on its own as a separate embodiment.

1. A valve, comprising: a valve frame having a distal end and a proximalend, and frame members defining an lumen; a valve leaflet having adistal end and a proximal end, where a portion of the distal end of thevalve leaflet is coupled adjacent to the proximal end of the valveframe; and a leaflet transition member coupled to at least a portion ofthe valve leaflet, where the leaflet transition member is a ringstructure that is coupled to the proximal end of the valve leaflet andthe valve leaflet and the leaflet transition member in a first positionare at least partially outside the lumen of the valve frame with theproximal end of the valve leaflet extending away from both the distalend and the proximal end of the valve frame, and where the valve leafletand leaflet transition member transition from the first position to asecond position in which the proximal end of the valve leaflet and atleast a portion of the leaflet transition member are within the lumen ofthe valve frame.
 2. The valve of claim 1, where the leaflet transitionmember is expandable from a first diameter to a second diameter.
 3. Thevalve of claim 2, where the leaflet transition member has the firstdiameter in the first position and the leaflet transition member expandsto the second diameter in the second position.
 4. The valve of claim 3,where the leaflet transition member has a serpentine shape in the firstposition in order to expand from the first diameter to the seconddiameter.
 5. The valve of claim 1, where the valve leaflet includes aleaflet frame coupled to a portion of a peripheral edge of the valveleaflet.
 6. The valve of claim 5, where the leaflet frame acts as theleaflet transition member.
 7. A method for deployment of a valve,comprising: radially expanding a valve frame of the valve from adelivery state to a deployed state; and transitioning a leaflettransition member coupled to a valve leaflet, where the leaflettransition member is a ring structure coupled to a proximal end of thevalve leaflet, in a first position outside a lumen of the valve frame toa second position inside the lumen of the valve frame.
 8. The method ofclaim 7, including coupling at least a portion of the leaflet transitionmember in the second position to the valve frame in the deployed state.9. The method of claim 7, where transitioning the leaflet transitionmember in the first position outside the lumen of the valve frame to thesecond position inside the lumen of the valve frame includes releasingthe leaflet transition member from the first position.
 10. The method ofclaim 9, including pushing the leaflet transition member in the firstposition from outside the lumen to the inside of the lumen of the valveframe.
 11. A system, comprising: an elongate delivery catheter; anexpandable balloon positioned around at least a portion of the elongatedelivery catheter; a retractable sheath positioned around at least aportion of the elongate delivery catheter, where the retractable sheathmoves longitudinally relative the elongate delivery catheter; and avalve, where a portion of the valve is positioned between the elongatedelivery catheter and the retractable sheath, and where the valveincludes a valve frame having frame members defining a lumen, a valveleaflet attached to a portion of the valve frame, and a leaflettransition member attached to at least a portion of the valve leaflet,where the leaflet transition member is a ring structure coupled to aproximal end of the valve leaflet and the valve leaflet and leaflettransition member extend away from the lumen of the valve frame in afirst position and transition into a second position in which the valveleaflet and leaflet transition member are inside the lumen of the valveframe.
 12. The system of claim 11, where the portion of the valvepositioned between the elongate delivery catheter and the retractablesheath is the leaflet transition member and a portion of the valveleaflet.
 13. The system of claim 12, where the retractable sheathrestrains the leaflet transition member in the first position.
 14. Thesystem of claim 11, further including a number of elongate push membersreleasably coupled to the leaflet transition member where the elongatepush members transition the leaflet transition member and the valveleaflet from the first position to the second position.
 15. The systemof claim 14, where the leaflet transition member has a serpentine shapein the first position in order to expand the leaflet transition memberfrom a first diameter to a second diameter.
 16. The system of claim 11,where the valve leaflet includes a leaflet frame coupled to a portion ofa peripheral edge of the valve leaflet.
 17. The system of claim 16,where the leaflet frame is hinged to a portion of the valve frame tocouple the valve frame and valve leaflet.